Suture Anchor Implantation Instrumentation System

ABSTRACT

A system for implanting an anchor into bone, the system comprising a curved cannulated guide for percutaneous insertion, having a proximal end and a distal end; a flexible drill insertable through the curved guide from the proximal end to the distal end, the flexible drill having a shaft having a flexible portion; and a flexible inserter for inserting a suture anchor into a bore at the anatomical site formed by the flexible drill, the flexible inserter having a shaft having a flexible portion, wherein the flexible portions of both the flexible drill and flexible inserter include a series of discrete, interlocking segments.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/215,147, filed Dec. 10, 2018 which is a continuation of U.S. patentapplication Ser. No. 15/371,914, filed Dec. 7, 2016 which is acontinuation of U.S. patent application Ser. No. 13/863,573, filed Apr.16, 2013, which is a continuation of U.S. patent application Ser. No.12/821,504, filed Jun. 23, 2010, now U.S. Pat. No. 8,439,947, which is acontinuation-in-part of U.S. patent application Ser. No. 12/460,310,filed Jul. 16, 2009, now U.S. Pat. No. 8,911,474, the disclosures ofwhich are hereby incorporated herein by reference.

BACKGROUND OF THE INVENTION

Various shoulder injuries may result from dislocations, falling,throwing, or lifting. A common shoulder injury includes the separationof the glenoid labrum from the glenoid. For example, a Bankart lesionresults from a labral tear that occurs in the anterioinferior region ofthe glenoid socket when the shoulder dislocates. A superior labralanterior posterior (SLAP) lesion typically occurs from throwinginjuries, where the tear occurs at the superior region of the glenoidsocket where the biceps tendon attaches to the shoulder. These injuriesresult in pain and instability of the shoulder joints.

Arthroscopic stabilization for surgical treatment of shoulderinstability has grown in popularity over the past decade. In particular,labral anchors have been employed to repair torn labrum tissue. Forexample, a labral anchor may be inserted into the glenoid, and a suturematerial that is attached to the labral anchor is used to reattach thetorn labral tissue to the glenoid.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the present invention may include an apparatusadapted for use with a surgical cannula for inserting a suture anchorinto an internal anatomical site may include a curved hollow guide foraccessing an internal anatomical site, having a proximal end and adistal end; a flexible oburator insertable through the curved guide fromthe proximal end to the distal end; a flexible drill insertable throughthe curved guide from the proximal end to the distal end; and a flexibleinserter for inserting a suture anchor into a bore at the anatomicalsite formed by the flexible drill, wherein the flexible drill andflexible inserter each may include a shaft having a flexible portionincluding a plurality of laser cuts. The shafts of the flexible drilland flexible inserter may further be substantially cannulated and mayinclude a thickness between an outer surface and an inner surface.Furthermore, the plurality of laser cuts of at least one of the flexibleportions of the flexible drill and flexible inserter may extendcircumferentially around the outer surface of the shaft and may extendat least partially through the thickness of the shaft. Moreover, theplurality of laser cuts may extend completely through the thickness ofthe shaft of at least one of the flexible drill and flexible inserter,such that the flexible portions of the flexible drill and flexibleinserter may be discrete, interlocking segments. Additionally, theshafts of the flexible drill and the flexible inserter may beconstructed from a material comprising hypodermic tubing, polymer, orstainless steel.

In another embodiment, the present invention may be a system forimplanting an anchor into bone, the system comprising a curvedcannulated guide for percutaneous insertion, having a proximal end and adistal end, a flexible obturator insertable through the curved guidefrom the proximal end to the distal end, a flexible obturator insertablethrough the curved guide from the proximal end to the distal end, aflexible drill insertable through the curved guide from the proximal endto the distal end, and a flexible inserter for inserting a suture anchorinto a bore at the anatomical site formed by the flexible drill.

In yet another embodiment, the present invention may be a system forimplanting an anchor into bone, the system comprising a cannulated guidecomprising a proximal end, a distal end positionable proximate a bone,and a curved shaft extending between the proximal and distal ends; adrill comprising a proximal end configured to receive torque, a distalrotary drilling head, and a shaft extending between the proximal end andthe rotary drilling head, wherein the shaft comprises a flexible portionand permits passage of the rotary drilling head through the shaft of thecannulated guide; and wherein one of the drill and the cannulated guidecomprises a stop feature shaped to interface with the other of the drilland the cannulated guide to adjustably control a maximum range of motionof the rotary drilling head through the cannulated guide.

In a further embodiment, the present invention may be a system forimplanting an anchor into bone, the system comprising a curvedcannulated guide for percutaneous insertion, having a proximal end and adistal end; a flexible drill insertable through the curved guide fromthe proximal end to the distal end, the flexible drill having a shafthaving a flexible portion; and a flexible inserter for inserting asuture anchor into a bore at the anatomical site formed by the flexibledrill, the flexible inserter having a shaft having a flexible portion,wherein the flexible portions of both the flexible drill and flexibleinserter include a series of discrete, interlocking segments. Theflexible portions may further include discrete, interlocking segmentswhich may be constructed from a material such as hypodermic tubing,stainless steel, polymer, or the like. The discrete, interlockingsegments may further be constructed from a solid, continuous length ofmaterial. These segments may also be constructed from the solid,continuous length of material by a laser cutting process, or the like.

The curved labrum instrumentation of the present invention will make theexisting SLAP and Bankart surgical procedures, in particular, the 5 and6 o'clock position repairs, easier to perform by making it possible toachieve anchor hole vectors that are much closer to perpendicular withthe surfaces of the scapular glenoid rim. This improved insertion vectorwill lessen the probability of anchor back out and thereby improve thequality of the surgical repair.

The instrumentation system of the present invention includes, in oneembodiment, four curved tubular guides and a straight tubular guide witheach guide including a cannulated handle, a hollow shaft, and aparabolic-shaped distal end aperture. The curved guides may be providedat any angle between and including 0 and 90 degrees. For example, thecurved guides of the system may have a curved angle of 12 or 25 degrees,in addition to the straight guide having no curved angle (i.e., 0degrees). As to the curved guides, the parabolic-shaped distal aperturemay have one of a standard or rotated orientation. A standardorientation may have the parabolic aperture aligned with the curve ofthe guide, while a rotated orientation may designate that the parabolicaperture is offset from the curve of the guide, for example, by 90degrees. Of course, a parabolic aperture on a straight guide would nothave an orientation as to a curved angle. The system also may include atleast one obturator which is placed at the distal end of each guide withthe obturator shaped as either a bullet or a trocar, or one of each maybe included. A drill is provided for insertion through any of the guidesfor forming a pilot hole in the glenoid rim for receiving a sutureanchor. The drill and the obturators may have flexible shafts allowingthe tips to traverse the curved portions of the curved guides.

The handle portion of each guide may provide the user with a place tograsp the instrument during use and, in the case of using the drill, toprovide a geometry that will prevent the user from drilling past a setdrill depth. The guide handle is also cannulated to allow for theinsertion of the flexible obturators, the flexible drill, and a flexibleinserter for the suture anchor.

The shaft portion of the guides may incorporate a curve at the distalend that achieves about 0 to about 90 degrees of bend, and specificallyabout 0 to about 25 degrees of bend, over a linear shaft distance of,for example, 1-3 inches. The distal tip of the guide shafts mayincorporate viewing windows that allow visual access to the drill andanchor inserter during surgical procedures and also has a “parabolic”design end aperture that is designed to physically mate with anatomicalfeatures of the glenoid to ensure proper and secure guide positioning. Alaser mark may also be located adjacent the distal tip to provide analignment feature to be used with laser marks on the drill and inserterfor depth gauging purposes.

Flexible obturators may be provided which, in one embodiment, consist ofa titanium handle, a flexible nitinol shaft, and a titanium tip. Arounded tip obturator utilizes a bullet-shaped tip, which functions toprotect the seal of a cannula (if used), and/or surrounding tissue, fromthe “parabolic” shaped edges of the 0°, 12° and 25° guides during theinsertion process of the guides into the joint space. A trocar tipobturator utilizes a trocar tip, which tip functions to puncture tissueduring the insertion of any of the guides into the joint space duringpercutaneous surgical approaches. Both obturators are designed to bereusable instruments and to be compatible with any of the suture anchorguides.

A flexible drill may be provided which may consist of three sections;(1) a proximal shaft, (2) a central shaft, and (3) a drill tip. Theproximal and central shafts may be of a continuous piece of materialwhich is laser welded to the drill tip, or alternatively the threesections of this instrument may be separate and laser welded together,though other methods of attachment known in the art may be used. Theproximal and central shaft portions consist of, for example machinedhypodermic tubing and functions to allow the attachment of an orthopedicpower drill driver to the proximal end and include geometry that allowsthe user to adjust the drilling depth. The center portion may, in oneembodiment, incorporate a flexible laser cut feature near its distal endthat allows the distal portion to flex without elastically orplastically deforming the material and thereby navigate the bend in theguide shaft. In a first embodiment, this may be accomplished viadovetail-shaped cuts which divide the tube into discrete yetinterlocking segments. The drill tip consists of a drill bit made ofmachined rod stock and is designed to drill a hole of appropriate depthand diameter in the surface of the scapular glenoid rim for the purposeof inserting a suture anchor such as a Stryker 3.5 mm TwinLoop™ sutureanchor.

A flexible suture anchor inserter may also be provided which may consistof a polymer handle over molded onto a flexible shaft assemblyconstructed of, for example, polymer and/or stainless steel. The shaftportion is capable of withstanding enough axial compression to allow thesuture anchor to be inserted into the drilled pilot hole withoutbuckling. The shaft is also flexible enough to facilitate anchorinsertion through the curved guide. The distal end of the inserter maybe rigid and substantially straight to remain straight as the anchor ismaneuvered into the bore hole. In one example, the distal end is made ofmetal, such as stainless steel, or another equally rigid material. Theshaft portion may be of solid construction which may be elasticallybendable. Alternatively, the shaft portion may be of a constructionsimilar to the shaft of the flexible drill, as discussed above, and maythus be constructed of interlocking segments which are formed in asimilar fashion as the shaft of the flexible drill.

In a further embodiment, a method of performing a surgical technique maycomprise inserting a curved hollow guide, and a flexible obturatorpositioned within the curved hollow guide, for accessing an internalanatomical site; removing the flexible obturator once the curved hollowguide is in place, inserting a flexible drill into the curved hollowguide; drilling a hole at the internal anatomical site; removing theflexible drill from the curved hollow guide; inserting a flexibleinserter into the curved hollow guide having a suture anchor engaged tothe distal end of the flexible inserter; inserting the suture anchorinto the hole at the internal anatomical site; and removing the curvedhollow guide and flexible inserter from the internal anatomical site. Inan alternative embodiment, a cannula may be used through which thecurved hollow guide may pass to reach the internal anatomical site.

The surgical techniques employed during the use of the instrumentationof the present invention are similar to those already used for SLAP andBankart surgical repairs. The curved geometry of this instrumentationmakes these surgical procedures easier to perform and more reliable andrepeatable. Initially, in a first embodiment, a cannula, such as aStryker Corp. 8 mm DriLok™ cannula, or any suitable cannula known in theart, may be placed in the shoulder in a standard fashion. Then anappropriate flexible obturator is placed inside an appropriate curvedguide and the curved guide is then inserted through the cannula and intothe joint capsule. Alternatively, in another embodiment, the appropriateguide can be inserted percutaneously into the joint capsule, without theuse of a cannula, and may be used with a trocar tip obturator, forexample. Once the guide is in place, the obturator is removed from thecurved guide. A flexible drill may then be inserted into the jointcapsule via the guide. A proximal end of the flexible drill is connectedto a standard orthopedic power drill and a pilot hole is drilled in theglenoid rim. The flexible drill is then removed from the guide. Aflexible inserter may then be inserted into the joint capsule via thecurved guide to insert a suture anchor previously placed thereon intothe pilot hole such as a Stryker Corp. 3.5 mm TwinLoop™ suture anchor.The flexible inserter is then removed from the guide. The guide is thenremoved from the cannula and the cannula removed (or alternatively, theguide is withdrawn from the surrounding tissue if no cannula is used).

The cannula may be included in the apparatus for inserting a sutureanchor into an internal anatomical site such as a glenoid. The systemmay include a cannula for accessing an internal anatomical site and acurved hollow guide for insertion into the cannula. The guide has aproximal end and a distal end. A flexible obturator is insertablethrough the curved guide from its proximal end to its distal end. Aflexible drill is also insertable through the curved guide from theproximal to the distal end. A flexible inserter is provided forinserting a suture anchor into a bore at the anatomical site formed bythe flexible drill. The curved hollow guide distal end may have a tipwith a pair of parallel edges formed by generally parabolic recesses inan aperture wall of the curved guide distal end. This type of distal endhas a contour shaped to engage a scapular glenoid rim of a shoulder. Thedistal end of the curved hollow guide may also have at least one windowextending through a wall thereof so the instruments inserted therein canbe viewed. The window is spaced from the distal tip of the curved hollowguide a distance allowing the viewing of a proximal end of a sutureanchor located adjacent the tip. The anatomical site may be a glenoidrim. The curved hollow guide may have a bend of 0° to 90°, and morespecifically 0° to 25°.

In an alternative embodiment, the system for implanting an anchor intobone may include a cannulated guide comprising a proximal end, a distalend positionable proximate a bone, and a shaft extending between theproximal and distal ends, the shaft having a curved shape, a drillcomprising a proximal end configured to receive torque, a rotarydrilling head, and a flexible shaft extending between the proximal endand the rotary drilling head. The guide shaft permits passage of therotary drilling head through the shaft of the cannulated guide. Theflexible shaft of the drill comprises a plurality of discrete grooves,each of which extends around the shaft to provide a flexibletransitional region, thereby dividing the shaft into a plurality ofrigid segments separated by the flexible transitional regions.

In yet another embodiment, the system for implanting an anchor intobone, the system has a cannulated guide comprising a proximal end, adistal end positionable proximate a bone, and a curved shaft extendingbetween the proximal and distal ends, a drill comprising a proximal endconfigured to receive torque, a distal rotary drilling head and a shaftextending between the proximal end and the rotary drilling head. Theshaft comprises a flexible portion and permits passage of the rotarydrilling head through the shaft of the cannulated guide. One of thedrill and the cannulated guide comprises a stop feature shaped tointerface with the other of the drill and the cannulated guide toadjustably control a maximum range of motion of the rotary drilling headthrough the cannulated guide. The stop feature may be threadably mountedon the drill proximal end.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a first embodiment of a suture anchor insertion system ofthe present invention;

FIG. 2 shows one embodiment of a 25° standard orientation curved hollowguide of the present invention;

FIG. 3 shows one embodiment of a 25° rotated orientation curved hollowguide of the present invention;

FIG. 4 shows one embodiment of a 12° standard orientation curved hollowguide of the present invention;

FIG. 5 shows one embodiment of a 12° rotated orientation curved hollowguide of the present invention;

FIG. 6 shows one embodiment of a 0° hollow guide of the presentinvention;

FIG. 7 shows one example of a handle which can be used with the guidesof FIGS. 2-6;

FIGS. 8-12 show multiple embodiments of the distal tip and apertureareas of the guides of FIGS. 2-6;

FIG. 13 shows one embodiment of a trocar tipped obturator for use withthe guides of FIGS. 2-6;

FIG. 14 shows one embodiment of a bullet tipped obturator for use withthe guides of FIGS. 2-6;

FIG. 15 shows one embodiment of a flexible drill for use with the guidesof FIGS. 2-6;

FIG. 16 shows a further embodiment of a bullet tip for use with theobturator of FIG. 14;

FIG. 17 shows a further embodiment of a trocar tip for use with theobturator of FIG. 13;

FIG. 18A shows one embodiment of a suture anchor inserter for use withthe guides of FIGS. 2-6;

FIG. 18B shows a cross-sectional view of the inserter of FIG. 18A;

FIGS. 19 and 21 show multiple embodiments of the tip of the inserter ofFIG. 18A with the tip shown in FIG. 21 being rotated 90° with respect tothe tip shown in FIG. 19;

FIGS. 20 and 22 show enlarged areas A and B of the tips of FIGS. 19 and21 respectively;

FIG. 23 shows a first embodiment of the insertion of one of the guidesof the present invention into a shoulder joint including an obturatorbullet tip for ease of insertion of the guide through a cannula forguiding the guides of the present invention into the joint area.

FIG. 24 shows an enlarged view of the obturator with a bullet tip asshown in FIG. 23;

FIG. 25 shows one of the guides of FIGS. 2-6 with the obturator removed.

FIG. 26 shows a pilot hole drilled in the rim of the glenoid using thedrill of FIG. 15 inserted through one of the guides of FIGS. 2-6;

FIG. 27 shows the inserter of FIG. 18A including an exemplary sutureanchor for insertion through one of the guides of FIGS. 2-6 into thepilot hole of FIG. 26;

FIG. 28 shows yet another embodiment of a suture anchor inserter for usewith the guides of FIGS. 2-6; and

FIG. 28A shows one embodiment of a distal end of the suture anchorinserter of FIG. 28.

DETAILED DESCRIPTION

Referring to FIG. 1 there is shown one embodiment of an instrumentationsystem of the present invention generally denoted as 10. The systemincludes various curved guides having a curved guide shaft with a curvedangle of between about 0° and about 90°. Specifically, the curved anglemay be about 0° to about 25°, though any other angle is envisioneddepending on the application of the guide. The system may consist of,for example, a 25° rotated orientation curved guide 12, a 25° standardorientation curved guide 14, a 12° rotated orientation curved guide 16,a 12° standard orientation curved guide 18, and a 0° (i.e. straight)guide 20. In one example, the rotated orientation guides may be used onthe posterior glenoid rim, and the standard orientation guides may beused on the anterior glenoid rim, though this may be reversed ifdesired. Furthermore, in an alternate example, the rotated orientationguides may be used within the posterior portal, and the standardorientation guides may be used within the anterior portal, or viceversa, depending upon the desires of the user and the surgicalapplication. The 0° guide may be rotated 90° and used on the anterior orposterior glenoid rim. Bullet tip obturator 22 and a trocar tipobturator 24 may also be provided and may be used for insertion throughthe cannulated opening in each of the guides 12, 14, 16, 18 and 20. Aflexible drill 26 may further be provided. The drill tip may be capableof drilling, for example, a 3.5 mm pilot hole. Finally a suture anchorinserter 28 may be provided which again has a flexible shaft and iscapable of receiving, for example, a 5 mm suture anchor which may eitherbe made of metal or a polymer such as polyetheretherketone (PEEK).

Referring to FIG. 2 there is shown a first embodiment of the 25°standard orientation curved guide 14 which includes a hollow tubularshaft 29 and handle 30 which is cannulated to allow the passage of thevarious other instruments of the system therethrough. FIG. 3 shows afirst embodiment of a 25° rotated orientation curved guide 12 having ashaft 31 also attached to a handle 30. Guides 14 and 12 include a distalend 32, 34 respectively having edges 36, 38 defining an aperture openingto the hollow anterior of each of the curved guide shafts. Distal ends32, 34 may include windows 42, in any form or shape, such as illustratedas elongated slats, in the walls of the shafts which allow the variousinstruments extending through the hollow interior of the shafts of thecurved guides 12, 14 to be viewed. In one embodiment, a window 42 may beon at least one side of the distal end of each guide.

Likewise FIG. 4 shows a first embodiment of a 12° standard orientationcurved guide 18. FIG. 5 shows a first embodiment of a 12° rotatedorientation curved guide 16. Again, both guides 18 and 16 include shafts44 and 46 which are tubular in shape and are received within cannulatedhandles 30. The shafts 44 and 46 are curved at 12° compared to the 25°curve of shafts 29 and 31. By this it is meant that the central axis ofthe straight part of the shaft adjacent the handle and the central axisat the tip 52, 54 of guides 18 and 16 form an angle of 12°.

Referring to FIG. 6 there is shown guide 20 having a hollow shaft 58 andcannulated handle 30 in which the cannulation through the shaft and thehandle are co-axial with the shaft 58 being straight thus having a 0°angle between the shaft part adjacent handle 30 and a distal shaft end62. While the standard and rotated orientations refer to the relativeposition of the aperture as to the curve of the shaft, it is understoodthat the guide 20 could have either orientation because the curve of theshaft is 0 degrees.

Referring to FIG. 7 there is shown one example of the handle 30 ofguides 12, 14, 16, 18 and 20 which may be ergonomically designed havinga helical groove formed for easy gripping. While the helically shapedhandle 30 is shown, any handle design may be utilized as long as it hasa cannulation adapted to receive the instruments 22, 24, 26 and 28 ofsystem 10.

Referring to FIGS. 8-12, there are shown the various embodiments of thetips of the guides 12, 14, 16, 18 and 20. While each tip embodiment isdesignated to a specific guide, it should be understood that each tipcan be used with each guide. The tip 32 of the 25° standard guide 14 isshown in FIG. 10 with the tip 34 of the 25° rotated guide 12 shown inFIG. 8. The 12° standard and rotated guides 18 and 16 are shown in FIGS.9 and 12 respectively and have distal tips 37 and 35 respectively. Thedistal tip of the straight or 0° guide 20 is illustrated in FIG. 11. Allthe guide tips have a “parabolic” shape to, among other reasons, allowbetter engagement with the rim of the glenoid. The orientation of the“parabolic” with respect to the curved section on curved guidesdetermine whether the orientation is standard or rotated, as isillustrated throughout the Figures. Each of the distal tips may have alaser marking 66 and, in the case of the curved guide, an arrow 68pointing to the direction of curvature. Obviously the arrow 68 isunnecessary for the straight or 0° guide 20. Laser mark 66 indicates thedesired depth of insertion of the instruments passing within the guides,and helps the user in achieving the specified depth of, for example,drilling into the bone or setting of the suture anchor. Each guide hasedges 70 and 72 extending between the inner and outer walls of thehollow guide which edge surfaces are generally parabolic in shape. Whilethe edges 70 and 72 form the parabolic shape are shown to be symmetric,they could be non-symmetric if such would better fit the anatomy.

Furthermore, edges 70 and 72 may include specific designs or dimensionsdepending on the requirements of anatomy or surgical procedure. Forexample, as illustrated in FIGS. 9 and 12, the aperture edge 70 or 72may include a flattened portion 73. The portion 73 may assist in movingthe guide through the cannula. This is particularly useful for the 12°guides, as shown, because the curve of the shaft may make it difficultfor the parabolic shape to pass through the cannula. This may also beuseful for the 25° guides, however, typically the 25° guide will be usedwithout a cannula and will be inserted percutaneously because the curveof the shaft may not fit through a cannula. Moreover, as illustrated inFIG. 12, an edge 70 or 72 may include a cut-out 74. Cut-out 74 mayfurther assist the passage of the curved guide through the cannula,while also providing sharpened points which may engage the bone andprovide a stable base on which the guide 16 can rest.

Referring to FIG. 13 there is shown one embodiment of an obturator 24including a trocar tip 80. The obturator may be made of a flexible shaft82 and a handle portion 84 with an adjustable stop surface 86 which canengage a proximal surface 88 of handle 30 as shown for example in FIG.7. The shaft 82 may be made from nitinol with trocar tip 80 being made,for example, of titanium. One embodiment of tip 80 is shown enlarged inFIG. 17 and has a bore 90 for receiving nitinol shaft 82 and a sharpenedpoint 92. Referring to FIG. 14 there is shown one embodiment of anobturator shaft 22 including a bullet tip 94 again with handle portion84 having a stop surface 86. Obturator 22 again may include a nitinolshaft 96 on which bullet tip 94 is mounted. Tip 94 is shown in anenlarged view in FIG. 16 which has a typical bullet shaped point 98 anda bore 100 for receiving shaft 96. Both tips 80 and 94 may be welded totheir respective shafts 82 and 96. The outer diameters of tip 80 and 94are sized to be slidingly received within the hollow bore of guides 12,14, 16, 18 and 20. The tips help prevent damage to the seal on the innerbore of the cannula. Also, trocar tip 80 may be used to cut throughtissue in percutaneous applications, while bullet tip 94 may also pushaside tissue when moving the guide within the body.

Referring to FIG. 15 there is shown drill 26 which includes a shaft 102which, in another embodiment, has a proximal solid portion 104 and aflexible portion 106. The flexible portion 106 is made by takinghypodermic metal tubing and forming a laser cut in the metal to asufficient depth to allow flexing about the cut. The shaft 102 may besubstantially cannulated and may include a thickness between an outersurface and an inner surface, such as would be the case with hypodermicmetal tubing, for example. The laser cut may extend circumferentiallyaround the outer surface of the hypodermic tubing and may have a wave orsinusoidal shape to enhance flexibility. For example, the laser cuts maymerely score the outer surface, or may penetrate deeper into thethickness of the shaft. The flexible portion is then laser welded ontothe solid rod of section 104. In a further embodiment, the laser cutsmay pass completely through the tubing to form discrete portions oftubing which may be interlocked by the shape of the cuts, for example,like jig-saw puzzle pieces, such that sections 104 and 106 may be asingle piece, and the laser cut may then be applied to the tubing atportion 106 to form the flexible portion. At the distal end of theflexible section 106 is a drill bit 108 which may be laser welded atpoint 109 to flexible portion 106. The drill bit 108 may have a diameterfor producing a pilot hole to receive a desired suture anchor such as a3.5 mm suture anchor. A proximal end 110 of flexible drill 26 includes adrive element 112 which may be inserted into a standard power drillchuck. Proximal end 110 also includes a stop feature for engagingsurface 88 of handle 30 to limit the depth of a pilot hole drilled inbone.

Referring to FIGS. 18A-22 there is shown one embodiment of the flexiblesuture anchor inserter 28 of the present invention. Referring to FIG.18A there is shown an elevation view of inserter 28 which can be seen incross-section in FIG. 18B. Inserter 28 has a handle 114 which iscannulated as is the shaft portion 116. Referring to FIGS. 19 and 21,FIG. 19 illustrates one example of the distal end 120 of shaft 116 withFIG. 21 showing shaft 116 rotated 90° with respect to the view shown inFIG. 19. FIGS. 20 and 22 show enlarged views A and B of the distal end120 including a laser marking 122 and u-shaped recessed areas 124 and126. As shown in FIG. 22 the tip 120 may also include an axiallyextending laser marking 130. Marking 130 may show the orientation of thesuture anchor attached to tip 120. For example, the vertical marking 130may show the orientation of a suture eyelet on the suture anchor. Tips120 including recesses 124, 126, are adapted to receive, for example, a3.5 mm Stryker TwinLoop™ suture anchor. Of course the tip can bedesigned to be utilized with any desirable suture anchor. Suture (notshown), which may be attached to the suture anchor, may then be passedup through the cannulated shaft and handle. Alternatively, the suturemay be positioned elsewhere relative to the suture anchor and inserter,as is known in the art.

FIGS. 28 and 28A illustrate another embodiment of a flexible sutureanchor inserter 128. Similar to the construction of the flexible drill26, above, a shaft portion 216 may include a solid portion 204 and aflexible portion 206. The flexible portion 206 is made using a length ofhypodermic metal tubing, or the like, and forming a laser cut in themetal to a sufficient depth to allow flexing about the cut. The shaft216 may be substantially cannulated and may include a thickness betweenan outer surface and an inner surface, such as would be the case withhypodermic metal tubing, for example. The laser cut may extendcircumferentially around the outer surface of the hypodermic tubing andmay have a wave, or sinusoidal shape to enhance flexibility. The cutsmay, in another arrangement, be a single cut which moves along at leasta portion of the shaft in a spiral pattern, like a thread on a screw.The laser cuts may be at any depth relative to the thickness of theshaft, such as, for example, cuts which merely score the outer surface,or cuts which may penetrate deeper into the thickness of the shaft. Theflexible portion is then laser welded onto the solid rod of section 204.In a further embodiment, the laser cuts may pass completely through thetubing to form discrete portions of tubing which may be interlocked bythe shape of the cuts, for example, like jig-saw puzzle pieces, suchthat sections 204 and 206 may be a single piece, and the laser cut maythen be applied to the tubing at portion 206 to form the flexibleportion. The cuts may be in a circumferential pattern, in a spiralpattern, or the like. At the distal end of the flexible section 206 is atip 220, which may be laser welded at point 209 to flexible portion 206.Alternatively, tip 220 may be a unitary piece, along with portions 204and 206, and is later machined as needed to accommodate a suture anchor.This interlocking flexible portion 206 may provide even strongerresistance to buckling when, for example, pressing the suture anchorinto the pilot hole.

The method of using the system 10 will now be explained. Referring toFIGS. 23 and 24 there is shown a schematic of the bones in the shoulderwhich include a clavicle 300, a coracoid process 302 and a proximalhumerus 304. A head 307 of the proximal humerus 304 engages a glenoid306. One guide chosen from guides 16, 18 and 20 may be placed in acannula 310 such that a tip 312 of the guide is located adjacent theglenoid 306. Guides 12 and 14 may also be used in this method, but dueto the 25° curvature, a cannula may not be used and percutaneous entrymay be used instead (though of course the use of a cannula capable ofhandling the 25° curved angle may allow these guides to be used with acannula). Likewise, any of guides 16, 18 and 20 may also be usedpercutaneously, without a cannula. An obturator 22 having a bulletshaped tip is shown in this method. Obturator 24 can be used if a trocartip 80 is required, especially for percutaneous entry. The cannula whichmay be used with this method may be any cannula known in the artsuitable for use with the guides of the present invention.

Referring to FIG. 24 there is an enlarged view of the distal tip 312 ofguide 308 with the bullet tip 94 of the obturator 22 extending beyondthe edges 322 of tip 312. As shown in FIG. 25 after the tip 312 of guide308 is properly located adjacent the glenoid 306, the obturator 22 isremoved with the guide 308 positioned as shown in FIG. 25. Using thelaser marked arrows 68 which may be pointed towards the curved sectionof the guide therefore allows the surgeon to orient the bend in a mannerto place the parabolic shaped edge 322 of the distal tip portion 312 onthe glenoid rim 306 at an appropriate location to perform the repair.The flexible drill 26 is then inserted through guide 308 and a pilothole 324 is drilled in the glenoid rim 306 as shown in FIG. 26. Thedrill tip 108 is visible in windows 42 of tip 312 prior to drilling thehole 324. The flexible drill 26 is then removed from the cannulated borein drill guide 308.

Referring to FIG. 27, a suture anchor 330 is then placed on the tip 120of an inserter 28 which again is placed through the cannulation ofhandle 30 and through the guide 308 into pilot hole 324 in the glenoidrim 306. Again the suture anchor would be visible in window 42 of tip312, and laser markings 66, 122 and 130 may be used to orient the sutureanchor to a proper depth into the bone and proper radial alignment(i.e., rotational alignment of suture eyelets) dependent upon aparticular application. After the suture anchor is firmly in position onrim 306 the inserter 28 is removed from guide 308. Additional sutureanchors may be implanted in the rim as desired. After the installationof suture anchors is complete the guide 308 and the cannula 310 areremoved.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. (canceled)
 2. A guide for accessing an internal anatomical sitecomprising: a hollow shaft having a longitudinal axis, an inner wall, anouter wall, a proximal end, and a distal end, the distal end having anedge extending between the inner and outer walls, the edge including afirst sharpened point and a second sharpened point, and the distal endincluding a flattened surface, wherein the flattened surface forms aportion of the outer wall including the first and second sharpenedpoints.
 3. The guide of claim 2, wherein the edge includes a first edgeand a second edge, and the first edge is positioned opposite the secondedge, the first edge having a first shape and the second edge having asecond shape, wherein the first shape includes the first and secondsharpened points and is different from the second shape.
 4. The guide ofclaim 3, wherein the flattened surface extends along at least a portionof the outer wall to the first edge.
 5. The guide of claim 3, whereinthe shaft includes a curvature along at least a portion of thelongitudinal axis, the first edge circumferentially aligning with aninner curve of the curvature.
 6. The guide of claim 5, wherein the firstshape of the first edge includes a cut-out that defines a parabolicaperture, wherein the cut-out aligns with one of an outer curve or aninner curve of the curvature.
 7. the guide of claim 6, wherein theparabolic aperture is positioned along the longitudinal axis.
 8. Theguide of claim 6, wherein the parabolic aperture is configured to matewith anatomical features of a glenoid.
 9. The guide of claim 5, whereinthe first shape of the first edge includes a cut-out that defines aparabolic aperture, wherein the cut-out is offset from an outer curveand an inner curve of the curvature.
 10. The guide of claim 2, whereinthe distal end terminates in the edge.
 11. The guide of claim 2, whereinthe shaft has a curved angle of about 0 degrees to about 90 degrees. 12.The guide of claim 2, wherein the shaft has a curved angle of about 0degrees to about 25 degrees.
 13. A system comprising: the guide of claim2; and a flexible drill capable of passing through the guide.
 14. Theguide of claim 2, wherein the guide is adapted to receive a flexibledrill.
 15. A guide for accessing an internal anatomical site comprising:a hollow shaft having a longitudinal axis, an inner wall, an outer wall,a proximal end, and a distal end, the distal end having a flattenedsurface forming a portion of the outer wall, wherein the hollow shaftincludes a curvature along at least a portion of the longitudinal axisand the flattened surface aligns with an inner curve of the curvature.16. The guide of claim 15, wherein flattened surface terminates in asharpened point extending in a distal direction on the distal end.
 17. Aguide for accessing an internal anatomical site comprising: a hollowshaft having a longitudinal axis, an inner wall, an outer wall, aproximal end, and a distal end, the distal end including a first edgeand a second edge defining a distal opening, the first edge including acut-out positioned between a first sharpened point and a secondsharpened point, and the outer wall including a flattened portionincluding the first and second sharpened points and the cut-out.
 18. Theguide of claim 17, wherein the cut-out has a parabolic shape.
 19. Theguide of claim 17, wherein the flattened portion extends along at leasta portion of the outer wall to the first edge, wherein the cut-out isalong at least part of the flattened portion.
 20. The guide of claim 17,wherein the shaft includes a curvature along at least a portion of thelongitudinal axis and the cut-out of the first edge aligns with one ofan outer curve or an inner curve of the curvature.
 21. The guide ofclaim 17, wherein the shaft includes a curvature along at least aportion of the longitudinal axis and the flattened portion aligns withan inner curve of the curvature.